Summary for ARTG Entry:
Koala Medical Pty Ltd - Proctoscope, rigid
ARTG entry for
Medical Device Included Class IIa
Koala Medical Pty Ltd
PO Box 1191,MONA VALE, NSW, 2103
ARTG Start Date
Medical Device Class IIa
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Evexar Medical Ltd
The Network Building 97 Tottenham Court
London, , W1T 4TP
1. Proctoscope, rigid
Single Device Product
35255 Proctoscope, rigid
A rigid endoscope intended to be used for observation, diagnosis, and treatment of the rectum and anus.It
is a single use, fully disposable device that utilises a dedicated, separate illuminator inserted into the base
of the handle,and a light rod to direct light to the end of the scope where it is most needed.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:07:43 AEDT
This is not an ARTG Certificate document.
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